What is Good Laboratory Practice?
Good Laboratory Practice (GLP) encompasses a set of principles for defining a framework within which laboratory or preclinical studies are planned, performed, monitored, recorded, reported, and stored for future reference.
The need for GLP
GLP was first instituted in the US when FDA (Food and Drug Administration) discovered numerous cases of wrong data submission and poor laboratory practices by toxicology labs and pharmaceutical companies across the United States.
Moreover, a reputed lab called Industrial Bio-Test covered the results of its preclinical studies where the testing of cosmetics had caused cancer and death of mice used in the study. Thus, the products were deemed fit for human consumption despite failure in preclinical studies.
So, in order to safeguard the quality, integrity, and safety of preclinical studies, FDA promulgated the Good Laboratory Practice Regulations on 22nd December 1978.
OECD (Organization for Economic Co-operation and Development) produced GLP principles of international standard in 1981. In 2002, National GLP-compliance Monitoring Authority (NGCMA) was established by the Department of Science and Technology, Government of India.
What are the objectives of GLP?
- It assures that the preclinical or lab study has utilized standard equipments and methods to conduct and report an experiment
- It makes sure that the data submitted to the regulatory authorities is in conjunction to what was found in the actual study
- It safeguards against any fraudulent activities by a study lab
- It promotes international acceptance of test results
What do GLP Principles say?
Following factors are considered in GLP:
- Ensure that the number of personnel involved in a preclinical study is sufficient and all are aptly qualified
- Maintain a record of the qualifications, training, and experience of the involved personnel
- Describe the job for each person involved in the study
- Establish and follow Standard Operational Procedures (SOP)
- Designate a study director for managing the overall conduct of preclinical studies.
His responsibilities include:
- Approval of the study protocol and make necessary amendments
- Ensuring that Quality assurance and other study personnel are updated with the study plans and SOP
- Ensuring SOP at periodic intervals and take any corrective action if needed
- Maintaining all records, data, and final report of the study
- The principal investigator of the study must ensure full compliance with GLP principles
- All personnel involved in the study must record all data in strict compliance with GLP principles, report any deviations to the study director, and take precautions for personal safety.
2.Quality Assurance Personnel (QAP)
An individual or a group is hired by the management to:
- Maintain copies of the study protocol and SOP
- Inspect the laboratories and people involved in the study for compliance with the approved protocol and report any deviations whatsoever
- State these inspections with dates in the final report
3.Facilities at the laboratory
- Sufficient and spacious rooms must be available for all stages of the study
- A safe storage area must be available for storing of raw data, reports, and specimens separate from the testing area
- Appropriate facilities for disposal and decontamination procedures must be present
4.Apparatus, materials, and reagents
- The apparatus used must be of appropriate design and adequate capacity
- All the equipments must be periodically cleaned, inspected, maintained, and calibrated according to SOP
- All chemicals, reagents, and solutions must be properly labelled with respect to their name, concentration, expiry date, and storage instructions
5.Storage of records and materials
Following records must be kept:
- Study plan, raw data, samples of test and reference items, specimens and final report of the study
- All inspections by QAP
- Qualifications, training, experience, and job description of all personnel
- Reports of maintenance and calibration of apparatus
- All SOP and its amendments
6.Reporting of study results
The study report must include the following:
- Starting and completion dates of study
- Materials and methods used with reference to the guidelines
- Information on test facility, sponsors, study director, principal investigator, and study personnel
- Details of inspection by QAP
- A summary of the test results with analysis and discussion
- Information about location of the specimen and data storage
7.Test and reference items and SOP
- All records pertaining to the items used in the experiment must be adequately maintained; their date of receipt, expiry date, and quantity used in the experiment
- Handling, sampling, and storage procedures must be identified
- SOPs should be available in written for test and reference items, apparatus, materials, and reagents, record keeping, reporting, storage and retrieval, test system, and quality assurance procedures
- Any deviation from SOP must be recorded and acknowledged by the study director or principal investigator
- All types of test materials, be it animal or plant must be stored and handled properly
- Newly received animals or plants must be kept separate for evaluation from the old ones
- All test materials must be stored in containers revealing information about the identity of the test material, its source, date of arrival, and arrival condition
Scope of GLP in India
GLP is applicable to the following procedures:
- Physical-chemical testing
- Toxicity studies
- Mutagenicity studies
- Studies on the effect of environmental toxins on aquatic and terrestrial organisms
- Studies on effect on natural ecosystems
- Analytical and chemical testing
How can study labs obtain a GLP certificate?
- Fill the prescribed application form which can be procured from NGCMA
- Inspection of the laboratory is carried out by GLP inspectors
- The inspection team prepares a report which is forwarded to the Technical Committee for recommendation to Chairman, NGCMA
- GLP-compliance certificate is given for 3 years
To conclude, you will be following GLP when you document your preclinical studies with complete honesty and do exactly what you write in the reports.